Rebecca Gentile | Director, Biologics AR&D
Merck

Rebecca Gentile is a Director in Biologics Analytical Research and Development (BARD) for Merck & Co., Inc.  She directs a lab of analysts to complete validation for separations assays, bioassays, and compendial testing in support of Merck's biologics pipeline, and to execute the assays to support release and stability testing to support clinical trial material. 

Ms. Gentile has held various roles during her 30-year career at Merck. Her experience started in the research analytical labs, and progressed within the manufacturing Quality organization to support stability for pharmaceutical, vaccine, and biologics programs.  She has designed global stability strategies and authored regulatory filings in support of development and commercial products, including support of drug substance, drug product, and medical device combination products.  She was instrumental in using stability data to support defining Merck's distribution strategy for commercial products.  She also held a Regulatory role, supporting global clinical and commercial filings for Merck’s products. 

Ms. Gentile holds a B.S. degree in Chemistry from The College of New Jersey (TCNJ) and an M.S. in Quality Assurance and Regulatory Affairs from Temple University.  She currently resides in PA with her husband and 2 sons, and enjoys playing clarinet and service as President of the Executive Board of the Eastern Wind Symphony.